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Comparing the pain relief effect of oral 10 percent glucose and expressed breast milk during venous blood sampling among hyperbilirubinemic neonates

Protocol summary

Summary
The aim of this study is to compare the pain relief effect of two methods, namely oral glucose 10 percent and expressed breast milk, in full term neonates during venous blood sampling among hyperbilirubinemic neonates. In this research, the population under study was the full term neonates who were allowed to be fed by mouth. These neonates were needed to be venipunctured, while have not received any sedative and palliative three hours before venipunturing, at least, as well as their mothers. Exclusion criteria for the study includes: regardless of reason it was not possible to do the 2nd venipuncture after the first one. Two sampling processes were constantly and accessibly done on a group of 35 infants, who were chosen randomly, in two days. At the first day the infants were fed breast milk, and on the second day they were fed 10 percent glucose. Each of the investigation on all of the infants have been done in two different days. Both days, infants were fed one milliliters of expressed breast milk or glucose 10 percent two minutes before blood sampling. The pain was measured using neonatal infant scale (NIPS). This instrument measures behavioral indexes of the infant (such as facial expressions, cry and state of arousal, arms and legs movement) and physiological indexes (such as breathing patterns). The measurement outcomes for each infant vary from zero to seven.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201109147557N1
Registration date: 2013-10-29, 1392/08/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-10-29, 1392/08/07
Registrant information
Name
Majid Noroozi Behjat
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3432 9607
Email address
majidnoroozi88@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kerman university of Medical Sciences
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the pain relief effect of oral 10 percent glucose and expressed breast milk during venous blood sampling among hyperbilirubinemic neonates
Public title
Comparing the pain relief effect of oral 10 percent glucose and expressed breast milk during venous blood sampling among hyperbilirubinemic neonates
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1. Full- term neonates (gestational age 37 to 42 weeks) who needed Venipuncture in order to control the neonatal bilirubin 2. No cotraindication for oral feeding. 3. Tranquilizers and painkillers had not been received at least 3 hours before blood sampling 4. The baby was awake before blood sampling 5. The mother had not received any drugs 6. The infant has not any anomalies, cleft lip and palate. 7. Mother was not diabetic. 8.Infants were fed breast milk of his/her own mother. 9. Clinical signs indicating an increase in bilirubin (according to physician diagnosis). Exclusion criteria for study: 1. neonate discharge before second blood sampling 2.oral feeding contraindication or treatment change during follow up due to an unexpected situation
Age
From 1 year old to 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 35
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Vice chancellor for research, Kerman University of Medical Sciences, Tahmasebabad Crossroads, Ibn Sina Street, Kerman
City
Kerman
Postal code
Approval date
2010-12-22, 1389/10/01
Ethics committee reference number
467/90/K

Health conditions studied

1

Description of health condition studied
Hyperbilirubinemia
ICD-10 code
P59.8
ICD-10 code description
Neonatal jaundice from other specified causes

Primary outcomes

1

Description
Pain intensity
Timepoint
2 minutes before blood sampling, intervention during 5 minutes, 3 minutes after intervention
Method of measurement
Pain scale measurement NIPS(Neonatale Infant Pain Scale)

Secondary outcomes

empty

Intervention groups

1

Description
expressed breast milk: one ml expressed breast milk once, two minutes before blood sampling.
Category
Prevention

2

Description
glucose 10 percent: one ml glucose 10 percent once, two minutes before blood sampling.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Aliebn Abitaleb(A)
Full name of responsible person
Majid Noroozi Behjat
Street address
Emam Ali Blvd, Rafsanjan
City
Rafsanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kerman University of Medical Sciences
Full name of responsible person
Dr. Reza Malekpour Afshar
Street address
Vice chancellor for research, Kerman University of Medical Sciences, Tahmasebabad Crossroads, Ibn Sina Street, Kerman
City
Kerman
Grant name
91/10/60/2389
Grant code / Reference number
90/467
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Majid Noroozi Behjat
Position
Student of Master degree in Neonatal Intensive Care Nursing
Other areas of specialty/work
Street address
Vice chancellor for research, Kerman University of Medical Sciences, Tahmasebabad Crossroads, Ibn Sina Street, Kerman
City
Kerman
Postal code
Phone
+98 34 1226 3787
Fax
Email
Majidnoroozi88@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of nursing and midwifery,Tehran University of Medical Sciences
Full name of responsible person
Zohreh Parsa Yekta
Position
Associate professor/Ph.D
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Faculty of Nursing and Midwifery,Tohid Sq, Nosrat Street
City
Tehran
Postal code
Phone
+98 21 6691 7171
Fax
Email
Zparsa@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Majid Noroozi Behjat
Position
Student of Master degree in Neonatal Intensive Care Nursing
Other areas of specialty/work
Street address
Vice chancellor for research, Kerman University of Medical Sciences, Tahmasebabad Crossroads, Ibn Sina Street, Kerman
City
Kerman
Postal code
Phone
+98 34 1226 3787
Fax
Email
Majidnoroozi88@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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